Using Endogenous Biomarkers to Derisk Assessment of Transporter‐Mediated Drug‐Drug Interactions: A Scientific Perspective

Author:

Arya Vikram1,Reynolds Kellie S.1,Yang Xinning2

Affiliation:

1. Division of Infectious Disease Pharmacology Office of Clinical Pharmacology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. Guidance and Policy Team Office of Clinical Pharmacology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference36 articles.

1. Clinical Drug–Drug Interaction Evaluations to Inform Drug Use and Enable Drug Access

2. Role of Transporters in Drug Development

3. Evaluation of transporters in drug development: Current status and contemporary issues

4. Regulatory Efforts to Facilitate Evaluation and Clinical Management of Drug‐Drug Interaction Risks

5. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER).In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme‐ and Transporter‐Mediated Drug Interactions Guidance for Industry. January2020.

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